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\begin{document}

\title{Criteria to evaluate efficacy of biologics in asthma: a Global Asthma
Association survey}



\author[1]{Angelica Tiotiu}%
\author[2]{Andras Bikov}%
\author[3]{Francisco-Javier Gonzalez-Barcala}%
\author[4]{Silviya Novakova}%
\author[5]{Plamena Novakova}%
\author[6]{Herberto Chong-Neto}%
\author[7]{Pierachille Santus}%
\author[8]{Ignacio J Ansotegui}%
\author[9]{Juan Carlos Ivancevich}%
\author[10]{Krzysztof Kowal}%
\author[11]{Stefan Mihaicuta}%
\author[5]{Denislava Nedeva}%
\author[12]{Giorgio Walter Canonica}%
\author[13]{Jonathan Bernstein}%
\author[14]{Louis-Philippe Boulet}%
\author[15]{Fulvio Braido}%
\affil[1]{Centre hospitalier regional universitaire de Nancy}%
\affil[2]{Wythenshawe Hospital}%
\affil[3]{Complejo Hospitalario Universitario de Santiago de Compostela}%
\affil[4]{UMBAL Sveti Georgi}%
\affil[5]{Medicinski universitet-Sofia}%
\affil[6]{Universidade Federal do Parana Hospital de Clinicas}%
\affil[7]{Universita degli Studi di Milano Dipartimento di Scienze Biomediche e Cliniche Luigi Sacco}%
\affil[8]{Hospital Quirónsalud Bizkaia}%
\affil[9]{Clínica Santa Isabel}%
\affil[10]{Medical University of Bialystok}%
\affil[11]{Center for Research and Innovation in Precision Medicine and Pharmacy}%
\affil[12]{Humanitas University}%
\affil[13]{University of Cincinnati Department of Internal Medicine}%
\affil[14]{Institut universitaire de cardiologie et de pneumologie de Quebec}%
\affil[15]{University of Genoa}%


\vspace{-1em}



  
  \date{May 19, 2024}


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\begin{abstract}
\textbf{Background}: Several biologics are now available as add-on
treatment for severe asthma but, currently there are no universally
accepted criteria to measure the response to these therapies. This
survey aims to establish consensus criteria to use in practice for the
initial evaluation of response to biologics after four months of
treatment. \textbf{Method:} Using Delphi methodology, a questionnaire
including ten items was developed and validated by a 13-member panel of
international experts in asthma. The electronic survey circulated within
the INterasma Scientific Network platform, Global Asthma Association
membership, contact list of the co-authors, national associations for
specialists, and social media. For each item, five answers were proposed
graduated from ``no importance'' to ``very high importance'' and by a
score (A=2 points; B=4 points; C=6 points; D=8 points; E=10 points). The
final criteria were selected if the median score for the item was [?]7 and
\textgreater{}60\% of responses accorded ``high importance'' and ``very
high importance''. All selected criteria were validated by the thirteen
experts. \textbf{Results}: Four criteria were identified to evaluate the
efficacy of biologics in asthma: to reduce daily systemic
corticosteroids dose by [?]50\% (ideally complete withdrawal); to decrease
the number of asthma exacerbations requiring systemic corticosteroids by
[?]50\%, (ideally no asthma exacerbation); to have no/minimal side-effects
and to obtain asthma control according validated questionnaires. The
consensual decision was that [?]3 criteria are needed to conclude a good
response to biologics. \textbf{Conclusions:} Specific criteria were
defined by an international panel of experts and could be used as tool
in clinical practice.%
\end{abstract}%



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